Fenestrated and Branched Endovascular Aortic Repair and Mortality at Hospitals Without Investigational Device Trials.

ABSTRACT:

Importance

Fenestrated and branched endovascular aortic repairs (F/BEVAR) have been adopted by many centers. However, national trends of F/BEVAR use remain unclear, particularly at sites who perform them without an US Food and Drug Adminstration (FDA)-approved investigational device exemption (IDE).

Objective

To quantify the use of F/BEVAR in the US and to determine if mortality was different at IDE vs non-IDE sites.

Design, setting, and participants

This retrospective cohort study examined 100% fee-for-service Medicare claims data from 2016 to 2023. Participants were patients who underwent endovascular treatment of the visceral aorta incorporating 2 or more visceral artery endoprostheses. Hospitals with vs without an IDE were identified using hospitals' Employer Iden

SUBMITTER: Zettervall SL 

PROVIDER: S-EPMC11822532 | biostudies-literature | 2025 Feb

REPOSITORIES: biostudies-literature